Comparison of BIOdegradable Polymer and DuRablE Polymer Drug-eluting Stents in an All COmeRs PopulaTion (BIO-RESORT)

Foundation of Cardiovascular Research and Education Enschede

Status: Completed

Conditions: Coronary Artery Disease; Coronary Restenosis; Acute Coronary Syndrome; Angina Pectoris; Angina, Unstable; Myocardial Infarction; Coronary Stenosis

Treatments: Device: Orsiro; Device: Synergy; Device: Resolute Integrity

Study type: Interventional

Funder types: Other

Identifiers

NCT01674803

BIO-RESORT

Details and patient eligibility

About

The introduction of drug-eluting stents (DES) in the treatment of coronary artery disease has led to a significant reduction in morbidity. However, the first generation of these devices had no positive impact on the mortality after PCI (compared to bare metal stents), which was greatly attributed to a somewhat increased incidence of late and very late stent thrombosis. Concerns about the role of durable polymers as a potential trigger of inflammation and finally adverse events also led to the development of DES with biodegradable coatings, which leave after degradation of the coating only a bare metal stent in the vessel wall that does not induce an inflammatory response. While such biodegradable polymer DES are increasingly used in clinical practice, there is no data available from head-to-head comparisons between biodegradable and contemporary third generation durable polymer DES.

Enrollment: 3,514 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Minimum age of 18 years.
• Significant coronary artery disease and lesion(s) eligible for treatment with drug eluting stents according to clinical guidelines and/or the operators' judgement.
• Capable of providing informed consent.
• Patients with all clinical syndromes will be enrolled without any exclusion based on number, type, location, or length of lesions to be treated.

Exclusion criteria

• Known intolerance to components of one of the stents that will be investigated or known intolerance to antithrombotic and/or anticoagulant therapy that prevents adherence to dual antiplatelet therapy.
• Planned elective surgical procedure necessitating interruption of dual antiplatelet therapy during the first 6 months after randomization.
• Participation in another randomized drug or device trial before reaching primary endpoint.
• Adherence to scheduled follow-up is unlikely or life expectancy assumed to be less than 1 year.
• Known pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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3,514 participants in 3 patient groups

Orsiro

Active Comparator group

Treatment:

Device: Orsiro

Synergy

Active Comparator group

Treatment:

Device: Synergy

Resolute Integrity

Active Comparator group

Treatment:

Device: Resolute Integrity